New multifunctional compounding mixer.

Abstract

The aim of research as to evaluate the usefulness of the new mixer Eprus® H2000 for the preparation of compounded drugs with different physicochemical properties, using the selected formulations. The verification of the process parameters of the mixer was based on the control of: mixing blades speed with a photo-optic tachometer and on the control of the heating system by measuring the water temperature in the mixing bowl during the process. Six compounded drugs in different forms were prepared for the tests, i.e.: glycerol solution of borax; non-ionic emulsifying ointment, ointment with boric acid, ointment with urea and salicylic acid, cream with vitamins A and E and in ichthammol pessasaries, for which it is necessary to mix the components at increased temperature and mixing speed. The quality of preparations was assessed on the basis of evaluation of the dosage form properties. The visual macroscopic verification included clarity of the solution, the presence of particulate contamination, coloration, uniformity of suspended substances in the ointment or pessaries, the presence of possible aggregates and the accuracy of moulds filling. Microscopic inspection was carried out to detect the variation of the dosage forms quality depending on the method of preparation. The particle size of boric acid and urea was analyzed using the Malvern Mastersizer 3000 laser diffractometer. The use of an appropriate method of preparation and optimal mixing parameters, i.e. mixing speed, time, and heating temperature, led to obtaining of good quality preparations, regardless of their form. All compounded drugs showed characteristics in accordance with pharmacopoeial requirements. The results of laser diffraction test confirmed the effectiveness of grinding solids using a new high-speed mixer. The median particle size (Dv(50)) of boric acid decreased approximately 5.5-fold, urea about 5.4-fold. Conclusions 1. Preparation of compounding drugs in Eprus® H2000 mixer ensures the obtaining of good quality products, regardless of the form of the drug. 2. The heating system and a mixing blades speed as high as 7500 rpm enable single-stage, one-container process, during which it is possible to dissolve or melt the components while heating, as well as to crumble and to crush solid ingredients.

Keywords

• pharmaceutical mixer
• quality of compounded drugs